Sotagliflozin

INPEFA

What it isDual SGLT1/SGLT2 inhibitor; heart-failure and cardiorenal risk reduction.

Why this oneSGLT1 blockade adds an intestinal effect, giving postprandial glucose control that pure SGLT2 inhibitors lack.

What limits itIntestinal blockade causes diarrhea; euglycemic ketoacidosis and genital fungal infection remain major hazards.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Heart failure	Adults	200 mg QD	400 mg QD	400 mg QD

Titration Up-titrate after at least 2 weeks (from 200 mg to 400 mg QD as tolerated)

Renal No specific dose adjustment; higher incidence of volume-depletion reactions in renal impairment; assess renal function before initiation

Hepatic Undefined

In decompensated heart failure, begin dosing once the patient is hemodynamically stable

Take once daily no more than 1 hour before the first meal of the day
Swallow tablets whole; do not cut, crush, or chew
Correct volume status before initiating
Withhold at least 3 days before major surgery or procedures with prolonged fasting
If a dose is missed by more than 6 hours, take the next dose the next day

Diabetic ketoacidosis (type 1 diabetes and others at risk)
Volume depletion / hypotension
Genitourinary infections incl. urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene), genital mycotic infections
Hypoglycemia with concomitant insulin or insulin secretagogues

Pregnancy Not recommended during the second and third trimesters (animal renal effects)

Lactation Not recommended while breastfeeding

NO BOXED WARNINGS

Principal riskDiarrhea from SGLT1 blockade; ketoacidosis in type 1

Cost, est. cash$300–$1,000/month

Generic entry2030 est.

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability3 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityAgent-specific hypoglycemia, ketoacidosis, volume, renal or gastrointestinal toxicity.

Box: minimal PK interactions